Join our growing Quality team and play a key role in ensuring compliance, performance, and continuous improvement across our medical device operations.
About the Role
As a Quality Engineer, you will support the maintenance and development of our Quality Management System, ensuring compliance with customer, regulatory, and internal requirements. You’ll work across the full product lifecycle—from concept through to production—contributing to high-quality outcomes across multiple production lines. This is a dynamic role where you’ll manage multiple projects, collaborate cross-functionally, and apply strong communication and problem-solving skills to drive quality excellence.
Key Responsibilities
Maintain quality system metrics and support validation, production, and change control activities
Partner with design and engineering teams on product development and design controls
Support risk management, design assurance, and design verification validation activities
Develop test methods, validation plans, protocols, and reports
Contribute to design reviews and maintain Design History Files
Support audits (internal, regulatory, and customer)
Lead quality activities from incoming inspection to final product release
Provide manufacturing support and quality expertise for product disposition
Drive continuous improvement and promote a strong quality culture
Work with suppliers to ensure compliance with quality standards
What We’re Looking For
Degree in Quality, Science, or Engineering
4+ years’ experience in a medical device design or manufacturing environment
Strong knowledge of FDA ISO 13485 quality systems
Experience with design assurance, validation, and manufacturing processes
Familiarity with statistical tools (e.g., Minitab) and Microsoft Office suite
Excellent communication and stakeholder management skills
Desirable
Experience in new product introduction (NPI) and process transfer
Knowledge of medical device standards and regulatory requirements
If you’re passionate about quality, innovation, and making an impact in the medical device industry, we’d love to hear from you.
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